Global Regulatory Affairs Leader - AI-Driven Strategy

Alexion Pharmaceuticals, Inc.; Boston (MA); Hybrid; USD 350,000 - 520,000; Full time

Job summary

Alexion Pharmaceuticals, Inc. is seeking a visionary VP, Head of Global Regulatory Affairs to drive global regulatory strategy across development and commercial portfolios.

You will lead relationships with FDA, EMA, PMDA, and other health authorities, and guide lifecycle management, labeling, and submissions worldwide. This role also leads digital and AI transformation in Regulatory Affairs, advancing data-driven decision making, regulatory intelligence, automation, and AI-enabled submission

Qualifications

• Advanced scientific degree (PhD, PharmD, MD, MS, or equivalent preferred).
• 20+ years of leadership experience in Global Regulatory Affairs.
• Proven track record delivering major global approvals and lifecycle expansions.
• Deep expertise across rare disease and/or specialty portfolios.
• Broad drug development experience from early development to commercialization.
• Strong FDA/EMA/PMDA engagement experience.
• Experience sponsoring digital transformation in Regulatory Affairs.

Responsibilities

• Lead the Global Regulatory Affairs organization and establish regulatory strategy aligned with corporate objectives.
• Oversee global regulatory submissions, approvals, labeling strategies, and maintenance.
• Represent the company with FDA, EMA, PMDA, and other health authorities.
• Lead digital and AI transformation of Regulatory Affairs, including data governance and automation.
• Collaborate with R&D, Medical, Commercial, Quality, Manufacturing, and Leadership teams to drive outcomes.

Skills

Regulatory leadership

Strategic thinking

Cross-functional collaboration

Digital transformation

AI in regulatory

Education

PhD/MD/PharmD/MS

Tools

Regulatory software

Data governance tools

Job description

Alexion Pharmaceuticals, Inc. is seeking a visionary VP, Head of Global Regulatory Affairs to drive global regulatory strategy across development and commercial portfolios.

You will lead relationships with FDA, EMA, PMDA, and other health authorities, and guide lifecycle management, labeling, and submissions worldwide. This role also leads digital and AI transformation in Regulatory Affairs, advancing data-driven decision making, regulatory intelligence, automation, and AI-enabled submission